NCT01287338终止2 期
A Randomized, Double-Masked, Placebo-Controlled, Proof of Concept Study to Evaluate the Short-term Safety and Efficacy of the QLT Proprietary Olopatadine Punctal Plug Delivery System in Subjects With Seasonal Allergic Conjunctivitis to Ragweed in an Environmental Exposure Chamber Model.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Safety of olopatadine-PPDS in subjects with seasonal allergic conjunctivitis to ragweed
研究概览
简要总结
The purpose of this study is to test if olopatadine punctal plugs can reduce the symptoms (itching) of allergic conjunctivitis to ragweed in an Environmental Exposure Chamber model.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of allergic conjunctivitis to ragweed for at least one year
- •Positive skin prick test to ragweed pollen within 12 months prior to visit 1
- •BCVA of at leat 20/400
排除标准
- •Structural lid abnormalities (ectropion, entropion)
- •Active lid disease ( ie moderate or severe blepharitis, meibomianitis) that requires medical treatment
- •Presence of follicular conjunctivitis, anterior uveitis or preauricular lymphadenopathy
- •History of ophthalmic abnormality, including a history of dry eye
- •Perennial allergic rhinoconjunctivitis having significant allergy to animal dander that cannot be avoided during the study period
- •History of chronic bacterial or viral ocular infection, such as herpes keratitis, and/or presence of active bacterial or viral ocular infection
- •presence of mucous discharge, excess lacrimation or burning as a symptoms of ocular disease
- •Currently on any chronic ocular topical medications
- •Use of topical or systemic ocular medications during the study period
- •History of complications, adverse events, trauma or disease in the nasolacrimal area
- •History of symptomatic epiphoria
研究组 & 干预措施
Lower Puncta Delivery
Experimental
干预措施: Olopatadine (Drug)
Double Puncta Delivery
Experimental
干预措施: Olopatadine (Drug)
结局指标
主要结局
Safety of olopatadine-PPDS in subjects with seasonal allergic conjunctivitis to ragweed
时间窗: 4 Days
Change from baseline in subject-rated ocular itching scores in treated vs placebo control arms in subjects with seasonal allergic conjunctivitis to ragweed
时间窗: 4 days
次要结局
- Change from baseline and observed values in subject rated ocular itching scores compared between lower puncta delivery and double puncta delivery arms(4)
研究者
研究点 (1)
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